Patient-reported outcomes in Danish implantable cardioverter defibrillator patients with a Sprint Fidelis lead advisory notification

Aims Few studies have investigated the association between implantable cardioverter defibrillators (ICDs) and lead advisory notifications and patient-reported outcomes (PROs). We examined (i) whether the mode used to inform patients about a device advisory is associated with PROs, and (ii) whether patients with a lead subject to a device advisory report poorer PROs than non-advisory controls. Methods and results Patients (n = 207) implanted with an ICD at Aarhus University Hospital, Denmark, with a Sprint Fidelis lead subject to an advisory and a non-advisory control group (n = 510), completed a set of standardized PRO measures. A Bon-ferroni correction was applied to all statistical PRO comparisons to adjust for multiple comparisons, with a P-value of 0.0038 (0.05/13 PROs) indicating statistical significance. Device advisory patients did not differ significantly on PROs according to mode of notification (all P-values.0.0038). They also did not differ significantly from controls on mean scores of depression, anxiety, device acceptance, and health status (all P>0.0038). Differences were only found on ICD concerns (P<0.0001) and on mental health status (P=0.003), with advisory patients reporting fewer ICD concerns and a better mental health status than non-advisory controls. Conclusions The mode used to inform ICD patients about the advisory was not associated with PROs, nor was the overall well-being of device advisory patients impaired compared to non-advisory controls. These results indicate that ICD patients are generally able to cope with a device advisory.